System for denervation

ABSTRACT

A method for manufacturing a shaping structure having a generally helical profile and configured to support electrodes for delivering electric energy into a cylindrical lumen of a patient. The method comprises providing a mandrel with a circular cylindrical shape and forming a first hole in the mandrel along the elongate axis, such that opposing ends of a bore of the first hole emerge at the proximal end and at the distal end; forming a second hole in the mandrel to extend from the curved surface to connect with the first hole; wrapping a metal wire around the mandrel; and inserting opposing ends of the metal wire into the second and the third hole respectively, and threading the opposing ends of the metal wire until they emerge from the opposing ends of the bore of the first hole; finally, heating the mandrel and the wire.

CROSS-REFERENCES TO RELATED APPLICATIONS

This divisional application claims priority from U.S. application Ser.No. 14/994,868, filed Jan. 13, 2016, incorporated by reference in itsentirety.

BACKGROUND

This invention relates to methods and devices for treatment of diseasesthat include congestive heart failure, chronic renal failure andhypertension. Specifically, the invention relates to improvingconditions in patients by modulating or blocking signals to the renalnerve.

Congestive Heart Failure (CHF) is a form of heart disease that isbecoming ever more common. The number of patients with CHF is expectedto grow in increasing numbers as the so-called “Baby Boomers” reach 50years of age. CHF is a health condition that occurs when the heartbecomes damaged, resulting in a reduced blood flow to the organs of thebody. If blood flow decreases sufficiently, kidney function becomesimpaired and results in fluid retention, abnormal hormone secretions andincreased constriction of blood vessels. These results increase thestress on the heart to do work, and further decrease the capacity of theheart to pump blood through the kidney and vascular circulation system.This reduced capacity further reduces blood flow to the kidney. It isbelieved that this cycle of reduced kidney perfusion is the principalnon-cardiac cause perpetuating a patient's downward spiral into CHF.Moreover, the fluid overload and associated clinical symptoms resultingfrom these changes are predominant causes for excessive hospitaladmissions, reduced quality of life and overwhelming costs to the healthcare system.

While many different diseases may cause initial damage to the heart,once such damage is present, CHF is identifiable under two types:Chronic CHF and Acute CHF. Despite its name, the chronic form is theless acute form of the two but is a longer term, slowly progressive,degenerative disease and may lead to cardiac insufficiency. Chronic CHFis clinically categorized by the patient's mere inability to exercise orperform normal activities of daily living.

By contrast, patients with Acute CHF may experience a more severedeterioration in heart function than those with Chronic CHF. The Acuteform results in the inability of the heart to maintain sufficient bloodflow and pressure to keep vital organs of the body alive. This conditioncan occur when extra stress (such as by infection) significantlyincreases the workload on the heart in a patient with an otherwisestable form of CHF. By contrast to a mere stepwise downward progressionthat is observable in patients with Chronic CHF, a patient sufferingAcute CHF may deteriorate rapidly from even the earliest stages of CHFto severe hemodynamic collapse. Moreover, Acute CHF can occur withinhours or days following an Acute Myocardial Infarction (AMI), which is asudden, irreversible injury to the heart muscle, identified in commonparlance as a heart attack.

Against this background, the kidneys are known to play an importantregulatory role in maintaining the homeostatic balance of the body. Thekidneys eliminate foreign chemicals from the body, regulate inorganicsubstances, and function as endocrine glands to secrete hormonalsubstances like renin and erythropoietin. The main functions of thekidney are to maintain the water balance of the body and controlmetabolic homeostasis by making the urine more or less concentrated,thus either reabsorbing or excreting more fluid. However, when renaldisease arises, some otherwise ordinary and regular physiologicalfunctions may become detrimental to the patient's health. When thisoccurs, the process is known as overcompensation. In the case of ChronicRenal Failure (CRF) the event of overcompensation may manifest itself ashypertension that has the effect of damaging the heart and bloodvessels, and can eventually result in a stroke or death. Thus, withoutproper function by the kidneys, a patient may suffer water retention,reduced urine flow, and an accumulation of waste toxins in the blood andbody. These conditions resulting from reduced renal function, or renalfailure (kidney failure), tend to increase the workload placed upon theheart. In a patient, simultaneous occurrence of both CRF and CHF maycause the heart to further deteriorate as the water build-up and bloodtoxins accumulate due to the poorly functioning kidneys and may, inturn, cause the heart further harm.

It has been observed, in connection with human kidney transplantation,that there is evidence to suggest that the nervous system plays a majorrole in kidney function. It was noted for example that after atransplant, when all the renal nerves are severed, the kidney wasobserved to increase excretion of water and sodium. This phenomenon hasalso been observed in animals when renal nerves are cut or chemicallydestroyed. The phenomenon has been termed “denervation diuresis” becausethe denervation acted on a kidney in a similar way to a diureticmedication. Later, observation of “denervation diuresis” was found to beassociated with vasodilatation of the renal arterial system that led tothe increase of the blood flow through the kidney. This observation wasconfirmed by the further observation in animals that reducing bloodpressure supplying the kidney could reverse the “denervation diuresis”.

It was also observed that after several months passed after kidneytransplant surgery in successful cases, the “denervation diuresis” intransplant recipients stopped, and the kidney function returned tonormal. Initially, it was believed that “renal diuresis” is merely apassing phenomenon and that the nerves conducting signals from thecentral nervous system to the kidney are not essential for kidneyfunction. Later discoveries led to the present generally held conclusionthat the renal nerves have an ability to regenerate, and that thereversal of the “denervation diuresis” is attributable to the growth ofthe new nerve fibers supplying kidneys with the necessary stimuli.

In summary then, it is known from clinical experience and also from theexisting large body of animal research that stimulation of the renalnerve leads to the vasoconstriction of blood vessels supplying thekidney, decreased renal blood flow, decreased removal of water andsodium from the body and increased renin secretion. It is also knownthat reduction of the sympathetic renal nerve activity, achieved byrenal denervation, can beneficially reverse these processes.

There has therefore already been identified a need in the art formethods and devices that may apply the observed effects set forth aboveto halt and reverse the symptoms of Congestive Heart Failure. Thus,certain methods and devices have already been developed in the art toreduce renal nerve activity, in order to meet the aforesaid need. Forexample, the following patents and applications are directed to thestated need: U.S. Pat. No. 8,347,891, and U.S. Application 2012/0143293,which are incorporated herein by reference. In some approachesconfigured to induce selective damage to the renal nerves (renaldenervation), manufacturers have developed and used radio frequency (RF)catheters, which, while being minimally invasive, have problems relatedto positioning electrodes within a vessel, and maintaining uniformcontact between the electrodes and the vessel wall. For example, incertain systems for denervation, treatment assemblies are used whichcomprise a helical shaping structure for supporting a plurality ofelectrodes which are deployed to place the electrodes in contact with avessel wall. Experience of using these systems reveals that problemsarise when attempting to force each electrode against the vessel wallwith an equal force, or approximately equal force. It is found, forexample, that some electrodes experience a greater contact force thanothers, even where the helical member is configured to have a helicaldiameter of constant magnitude over its length.

Thus, there is a need in the medical arts to produce a system and methodfor RF-based renal therapy which is relatively simple, accurate,effective, and produces an enhanced measure of electrode appositioncontrol. The present invention addresses these and other needs

SUMMARY OF THE INVENTION

In some embodiments, the invention includes a method for manufacturing ashaping structure having a generally helical profile and configured tosupport electrodes for delivering electric energy into a cylindricallumen of a patient. The method comprises providing a mandrel with acircular cylindrical shape and having a proximal end and a distal end, acurved surface between the proximal end and the distal end, and anelongate axis. A first hole is formed in the mandrel along the elongateaxis, such that opposing ends of a bore of the first hole emerge at theproximal end and at the distal end. A second hole is formed in themandrel to extend from the curved surface to connect with the firsthole, the second hole lying in a first radial plane of the mandrel. Athird hole is formed in the mandrel to extend from the curved surface toconnect with the first hole, the third hole lying in a second radialplane of the mandrel. A metal wire is wrapped around the mandrel in anarea of the mandrel between the second hole and the third hole. Opposingends of the metal wire are inserted into the second and the third holerespectively, and threading the opposing ends of the metal wire untilthey emerge from the opposing ends of the bore of the first hole. Atthis stage, the mandrel and the wire are heated. In some embodiments,wrapping a metal wire around the mandrel includes wrapping a wire formedof shape memory metal, which may be in some embodiments, a wire formedof a Nickel Titanium alloy. In some embodiments, forming a first holealong the elongate axis comprises forming a first hole that isdiscontinuous in extent between proximal end and distal end. In someembodiments, forming a second hole includes forming a second hole thatforms an angle of between 70 degrees and 90 degrees with the elongateaxis. This feature will impart desirable characteristics to the shapingstructure. In some embodiments, forming a third hole includes forming athird hole that forms an angle of between 70 degrees and 90 degrees withthe elongate axis. This feature imparts the same desirablecharacteristics. In some embodiments, the mandrel may be formed ofmetal, but it may also be formed of a ceramic material. In someembodiments, the first radial plane and the second radial plane are notoffset from each other, whereby the wire is wrapped a fullcircumferential loop around the mandrel. However, in other embodiments,the first radial plane and the second radial plane are offset from eachother, whereby the wire is wrapped between 1.0 and 1.5 circumferentialloops around the mandrel. In some embodiments, forming a first holeincludes forming a first hole by molding a ceramic material while theceramic material is malleable, while in other embodiments, forming afirst hole includes forming a hole by drilling. In some embodiments,heating the mandrel and wire includes heating to a temperature ofbetween 510° F. and 540° F., and in some embodiments, the time forheating is a period of between 4.5 minutes and 5.5 minutes. In someembodiments, the mandrel and wire are quenched in water.

In another embodiment the invention is a shaping structure having agenerally helical profile and configured to support electrodes fordelivering electric energy into a cylindrical lumen of a patient. Theshaping structure comprises a wire formed of metal, and having ageometric shape described according to a three dimensional orthogonalcoordinate system having an x-axis, a y-axis, and a z-axis. The wire isformed to include a first element extending along the x-axis such thaty=0, z=0 at all points on the first element; a second element extendingalong the x-axis such that y=0, z=0 at all points on the second element;and a third element, positioned between and operably connected with thefirst element and the second element, wherein the third element followsa spiral path with an axial length, a pitch, p, and a helical radius, r,about the x axis such that for any point on the third element, y=r*cost, z=r*sin t, x=p*(t/2π), where t is a parameter having a dimension inradians. The third element is connected to the first element by a firstconnector that is straight and extends between a proximal end of thefirst element and a distal end of the third element, wherein the firstconnector forms an angle of between 70 degrees and 90 degrees with thex-axis. In further embodiments, the third element is connected to thesecond element by a second connector that is straight and extendsbetween a distal end of the second element and a proximal end of thethird element, wherein the second connector forms an angle of between 70degrees and 90 degrees with the x-axis. In some embodiments, the firstelement and the second element are each between 10 and 20 mm in length.In some embodiments, the pitch is between 10 mm and 15 mm. In furtherembodiments, the radius is between 6 mm and 12 mm. In some embodiments,the wire is formed of shape memory metal, and has a diameter of between1.0 mm and 2.0 mm, and the length is between 10 mm and 20 mm.

These and other advantages will become clearer when read in conjunctionwith the drawings and the detailed description of preferred embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

Many aspects of the present disclosure can be better understood withreference to the following drawings. The components in the drawings arenot necessarily to scale. Instead, emphasis is placed on illustratingthe principles of the present disclosure.

FIG. 1 illustrates an intravascular renal neuromodulation systemconfigured in accordance with an embodiment of the present technology.

FIG. 2 illustrates modulating renal nerves with a multi-electrodecatheter apparatus in accordance with an embodiment of the presenttechnology.

FIG. 3A is a view of a distal portion of a catheter shaft and amulti-electrode array in a delivery state (e.g., low-profile orcollapsed configuration) within a renal artery used in conjunction witha guide catheter in accordance with an embodiment of the presenttechnology.

FIG. 3B is a view of the distal portion of the catheter shaft and themulti-electrode array of FIG. 3A in a deployed state (e.g., expandedconfiguration) within a renal artery in accordance with an embodiment ofthe technology.

FIG. 4A is a schematic side view of an embodiment of the presenttechnology, shown in an expanded condition for deployment.

FIG. 4B is a schematic side view of the embodiment of FIG. 4A, shown ina collapsed condition for delivery.

FIG. 5A is a schematic perspective view of an electrode positioned on ashaping structure.

FIG. 5B is a sectional view of the view seen in FIG. 5A.

FIG. 5C is a schematic view of an embodiment showing electrical leadline connecting to an electrode.

FIG. 6A is a sectional view of a shaping mandrel having features of theinvention.

FIG. 6AA is an end view of the shaping mandrel seen in FIG. 6A.

FIG. 6AB is and end view of another embodiment of a shaping mandrel.

FIG. 6B is a sectional view of another embodiment of a shaping mandrelhaving features of the invention.

FIG. 6C is a sectional view of yet a further embodiment of a shapingmandrel having features of the invention.

FIG. 7 is a side elevational view of a shaping mandrel in conjunctionwith a shaping structure, according to one embodiment.

FIG. 8 is a perspective view of the shaping mandrel seen in FIG. 7.

FIG. 9 is a side elevational view of a further embodiment of a treatmentassembly having features of the invention, shown in a first expandedcondition.

FIG. 10 is an end view of the treatment assembly exemplified in FIG. 9.

FIG. 11 is a side elevational view of the treatment assembly of FIG. 9,shown in a second collapsed condition.

FIG. 12 is a side elevational view of one embodiment of a component ofthe invention, shown in conjunction with a coordinate axis system.

FIG. 13 is an end view of the component shown in FIG. 12, shown inconjunction with the coordinate system.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The applicants base the present application on the known discovery, asset forth above, that it may be desirable to perform a denervationtreatment of the renal artery (renal denervation, or, renalneuromodulation) to positively affect a medical condition. Inembodiments of the invention, such treatment may apply energy to zonesof the renal artery normal to the artery wall. In some treatments,energy may be applied circumferentially. However, continuouscircumferential lesions that extend continuously about a full 360° ofthe circumference of a cross-section normal to the body lumen or tissuein proximity to the body lumen may increase a risk of acute and/or latestenosis formation within the blood vessel. Therefore, embodimentsdescribed herein are directed to forming discrete lesions that do notform a circle in a single plane normal to the axis of the vessel.

Embodiments herein are configured to provide a non-continuouscircumferential treatment that is performed over a lengthwise segment ofthe blood vessel (body lumen), as compared to a continuouscircumferential treatment at a single normal cross-section or radialplane. Target structures such as nerves, including nerve fiber bundles,extending along the longitudinal dimension of the vessel are thuscircumferentially affected, but not in continuous circumference about asingle point of the vessel. Thus, the resulting lesion does not form acontinuous circumferential lesion along any normal cross-section orradial plane of the vessel, but rather forms a helical lesion that mayin some embodiments be a continuous helical lesion or in otherembodiments a helical lesion with discontinuities along its path. Thishelical characteristic is believed to reduce the risk of acute or latestenosis formation within the blood vessel (body lumen) when comparedwith lesions that are formed to extend around a normal cross section ofthe vessel in single plane.

The non-continuous circumferential treatment is achieved in embodimentsof the invention via apparatus positioned within a body lumen inproximity to target neural fibers for application of energy to thetarget neural fibers. The treatment may be induced, for example, via theapplication of electrical and/or electro-magnetic energy. Such treatmentmay be achieved, for example, via a thermal or non-thermal electricfield, via a continuous or pulsed electric field, or via a stimulationelectric field.

In some embodiments, methods and apparatus for real-time monitoring ofthe treatment and its effects on the target or support structures,and/or in non-target tissue, may be provided. Likewise, real-timemonitoring of the energy delivery apparatus may be provided. Power ortotal energy delivered, impedance and/or the temperature, or othercharacteristics of the target or non-target tissue, or of the apparatus,additionally or alternatively may be monitored.

When utilizing an electric field to achieve desired circumferentiallynon-continuous treatment, the electric field parameters may be alteredand combined in any combination, as desired. Such parameters caninclude, but are not limited to, frequency, voltage, power, fieldstrength, pulse width, pulse duration, the shape of the pulse, thenumber of pulses and/or the interval between pulses (e.g., duty cycle).

When utilizing thermal or indirect thermal mechanisms to achieve thedesired treatment, protective elements may be provided to protect thenon-target tissue (such as the smooth muscle cells) from thermal damageduring the thermally-induced non-continuous circumferential treatment.For example, when heating target nerves or support structures locatedabout a vessel, protective cooling elements, such as convective coolingelements, may be provided to protect the non-target tissue. Likewise,when cooling target nerves or support structures, protective heatingelements, such as convective heating elements, may be utilized toprotect the non-target tissue. Thermal energy may be applied eitherdirectly or indirectly for a brief or a sustained period of time inorder to achieve, for example, desired neuromodulation or denervation.Feedback, such as sensed temperature and/or impedance, along target ornon-target tissue or along the apparatus, may be used to control andmonitor delivery of the thermal energy.

The non-target tissue optionally may be protected during, e.g., theneuromodulation or denervation, by utilizing blood flow as a conductiveand/or convective thermal sink that absorbs excess thermal energy (hotor cold). For example, when blood flow is not blocked, the circulatingblood may provide a relatively constant temperature medium for removingthe excess thermal energy from the non-target tissue during theprocedure. The non-target tissue additionally or alternatively may beprotected by focusing the thermal (or other) energy on the target orsupport structures, such that an intensity of the energy is insufficientto induce thermal damage in the non-target tissue distant from thetarget or support structures.

Embodiments of Catheter Apparatus

FIG. 1 illustrates a renal neuromodulation system 10 configured inaccordance with an embodiment of the present technology. The system 10includes an intravascular intraluminal device 12 operably coupled to anenergy source or energy generator 26. In the embodiment shown in FIG. 1,the intraluminal device 12 (e.g., a catheter) includes an elongatedshaft 16 having a proximal portion 18, a handle 34 at a proximal regionof the proximal portion 18, and a distal portion 20 extending distallyrelative to the proximal portion 18. (As used herein, the term“operably” connected or coupled means that a connection is formed butpermits an indirect connection wherein a further element may be placedbetween two elements that are operably connected to each other. Theintraluminal device 12 further includes a treatment assembly ortreatment section 21 at the distal portion 20 of the shaft 16. Asexplained in further detail below, the treatment assembly 21 can includean array of two or more electrodes 24 configured to be delivered to arenal blood vessel (e.g., a renal artery) in a low-profileconfiguration. Upon delivery to the target treatment site within therenal blood vessel, the treatment assembly 21 is further configured tobe deployed into an expanded state (e.g., a generally helical or spiralconfiguration) for delivering energy at the treatment site and providingtherapeutically-effective electrically- and/or thermally-induced renalneuromodulation. In some embodiments, the treatment assembly 21 may beplaced or transformed into the deployed state or arrangement via remoteactuation, e.g., via an actuator 36, such as a knob, pin, or levercarried by the handle 34. In other embodiments, however, the treatmentassembly 21 may be transformed between the delivery and deployed statesusing other suitable mechanisms or techniques.

The proximal end of the treatment assembly 21 is carried by or affixedto the distal portion of the elongated shaft 16. A distal end of thetreatment assembly 21 may terminate the intraluminal device 12 with, forexample, an atraumatic rounded tip or cap. Alternatively, the distal endof the treatment assembly 21 may be configured to engage another elementof the system 10 or intraluminal device 12. For example, the distal endof the treatment assembly 21 may define a passageway for engaging aguide wire 66 for delivery of the intraluminal device usingover-the-wire (“OTW”) or rapid exchange (“RX”) techniques.

The energy source or energy generator 26 (e.g., a RF energy generator)is configured to generate a selected form and magnitude of energy fordelivery to the target treatment site via the electrodes 24. The energygenerator 26 can be electrically coupled to the intraluminal device 12via a cable 28. At least one supply wire (not shown) passes along theelongated shaft 16 or through a lumen in the elongated shaft 16 to theelectrodes 24 and transmits the treatment energy to the electrodes 24.In some embodiments, each electrode 24 includes its own supply wire. Inother embodiments, however, two or more electrodes 24 may beelectrically coupled to the same supply wire. A control mechanism, suchas foot pedal 32, may be connected (e.g., pneumatically connected orelectrically connected) to the energy generator 26 to allow the operatorto initiate, terminate and, optionally, adjust various operationalcharacteristics of the generator, including, but not limited to, powerdelivery. The system 10 may also include a remote control device (notshown) that can be positioned in a sterile field and operably coupled tothe electrodes 24. The remote control device is configured to allow forselectively turning on/off the electrodes. In other embodiments, theremote control device may be built into the handle assembly 34. Theenergy generator 26 can be configured to deliver the treatment energyvia an automated control algorithm and/or under the control of theclinician. In addition, the energy generator 26 may include one or moreevaluation or feedback algorithms to provide feedback to the clinicianbefore, during, and/or after therapy.

In some embodiments, the system 10 may be configured to provide deliveryof a monopolar electric field via the electrodes 24. In suchembodiments, a neutral or dispersive electrode may be electricallyconnected to the energy generator 26 and attached to the exterior of thepatient (as shown in FIG. 2). Additionally, one or more sensors (notshown), such as one or more temperature (e.g., thermocouple, thermistor,etc.), impedance, pressure, optical, flow, chemical or other sensors,may be located proximate to or within the electrodes 24 and connected toone or more supply wires (not shown). For example, a total of two supplywires may be included, in which both wires could transmit the signalfrom the sensor and one wire could serve dual purpose and also conveythe energy to the electrodes 24. Alternatively, a different number ofsupply wires may be used to transmit energy to the electrodes 24.

The energy generator 26 may be part of a device or monitor that mayinclude processing circuitry, such as a microprocessor, and a display.The processing circuitry may be configured to execute storedinstructions relating to a control algorithm. The monitor may beconfigured to communicate with the intraluminal device 12 (e.g., viacable 28) to control power to the electrodes 24 and/or to obtain signalsfrom the electrodes 24 or any associated sensors. The monitor may beconfigured to provide indications of power levels or sensor data, suchas audio, visual or other indications, or may be configured tocommunicate the information to another device. For example, the energygenerator 26 may also be configured to be operably coupled to a catheterlab screen or system for displaying treatment information.

FIG. 2 illustrates modulating renal nerves with an embodiment of thesystem 10. The intraluminal device 12 provides access to the renalplexus RP through an intravascular path P, such as a percutaneous accesssite in the femoral (illustrated), brachial, radial, or axillary arteryto a targeted treatment site within a respective renal artery RA. Asillustrated, a section of the proximal portion 18 of the shaft 16 isexposed externally of the patient. By manipulating the proximal portion18 of the shaft 16 from outside the intravascular path P, the clinicianmay advance the shaft 16 through the sometimes tortuous intravascularpath P and remotely manipulate the distal portion 20 of the shaft 16.Image guidance, e.g., computed tomography (CT), fluoroscopy,intravascular ultrasound (IVUS), optical coherence tomography (OCT), oranother suitable guidance modality, or combinations thereof, may be usedto aid the clinician's manipulation. Further, in some embodiments, imageguidance components (e.g., IVUS, OCT) may be incorporated into theintraluminal device 12 itself. After the treatment assembly 21 isadequately positioned in the renal artery RA, it can be radiallyexpanded using the handle 34 or other suitable means until theelectrodes 24 are in stable contact with the inner wall of the renalartery RA. The purposeful application of energy from the electrodes 24is then applied to tissue to induce one or more desired neuromodulatingeffects on localized regions of the renal artery and adjacent regions ofthe renal plexus RP, which lay intimately within, adjacent to, or inclose proximity to the adventitia of the renal artery RA. The purposefulapplication of the energy may achieve neuromodulation along all or atleast a portion of the renal plexus RP.

The neuromodulating effects are generally a function of, at least inpart, power, time, contact between the electrodes 24 and the vesselwall, and blood flow through the vessel. The neuromodulating effects mayinclude denervation, thermal ablation, and non-ablative thermalalteration or damage (e.g., via sustained heating and/or resistiveheating).

Turning now to a more detailed description of certain embodiments, FIG.3A is a schematic side view illustrating one embodiment of the distalportion of the shaft 16 and the treatment assembly 21 in a deliverystate (e.g., low-profile or collapsed configuration) within a renalartery RA, and FIG. 3B illustrates the treatment assembly 21 in adeployed state (e.g., expanded or helical configuration) within therenal artery. Referring first to FIG. 3A, the collapsed or deliveryarrangement of the treatment assembly 21 defines a low profile about thelongitudinal axis A-A of the assembly such that a transverse dimensionof the treatment assembly 21 is sufficiently small to define a clearancedistance between an arterial wall 55 and the intraluminal device 12. Thedelivery state facilitates insertion and/or removal of the intraluminaldevice 12 and, if desired, repositioning of the treatment assembly 21within the renal artery RA.

The distal portion 20 of the shaft 16 may flex in a substantial fashionto gain entrance into a respective left/right renal artery by followinga path defined by a guide catheter, a guide wire, or a sheath. Forexample, the flexing of distal portion 20 may be imparted by the guidecatheter 90, such as a renal guide catheter with a preformed bend nearthe distal end that directs the shaft 16 along a desired path, from thepercutaneous insertion site to the renal artery RA. In anotherembodiment, the intraluminal device 12 may be directed to the treatmentsite within the renal artery RA by engaging and tracking a guide wire(e.g., guide wire 66 of FIG. 2) that is inserted into the renal arteryRA and extends to the percutaneous access site. In operation, the guidewire is preferably first delivered into the renal artery RA and theelongated shaft 16 comprising a guide wire lumen is then passed over theguide wire into the renal artery RA.

After locating the treatment assembly 21 at the distal portion 20 of theshaft 16 in the renal artery RA, the treatment assembly 21 istransformed from its delivery state to its deployed state or deployedarrangement. The transformation may be initiated using an arrangement ofdevice components as described herein with respect to the particularembodiments and their various modes of deployment. As described ingreater detail below and in accordance with one or more embodiments ofthe present technology, the treatment assembly may be deployed by adeployment member, such as for example a pull- or tension-wire engagedwith the shaping structure of the treatment assembly to apply adeforming or shaping force to the assembly to transform it into itsdeployed state.

Further manipulation of the shaping structure 22 and the electrodes 24within the respective renal artery RA establishes apposition of theelectrodes 24 against the tissue along an interior wall of therespective renal artery RA. For example, as shown in FIG. 3B, thetreatment assembly 21 is expanded within the renal artery RA such thatthe electrodes 24 are in contact with the renal artery wall 55.

As best seen in FIG. 3B, in the deployed state, the treatment assembly21 defines a substantially helical shaping structure 22 in contact withthe renal artery wall 55 along a helical path. One advantage of thisarrangement is that pressure from the shaping structure can be appliedto a large range of radial directions without applying pressure to acircumference of the vessel. Thus, the helically-shaped treatmentassembly 21 is configured to provide stable contact between theelectrodes 24 and the artery wall 55 when the wall moves in anydirection. Furthermore, pressure applied to the vessel wall 55 along ahelical path is less likely to stretch or distend a circumference of avessel that could thereby cause injury to the vessel tissue. Stillanother feature of the expanded shaping structure is that it may contactthe vessel wall in a large range of radial directions and maintain asufficiently open lumen in the vessel allowing blood to flow through thehelix during therapy.

As best seen in FIG. 3B, in the deployed state, the shaping structure 22defines a maximum axial length of the treatment assembly 21 that isapproximately equal to or less than a renal artery length 54 of a mainrenal artery (i.e., a section of a renal artery proximal to abifurcation). Because this length can vary from patient to patient, itis envisioned that the deployed helical-shaped shaping structure 22 maybe fabricated in different sizes (e.g., with varying lengths and/ordiameters) that may be appropriate for different patients. Referring toFIG. 3B, in the deployed state, the helical-shaped treatment assembly 21provides for circumferentially discontinuous contact between theelectrodes 24 and the inner wall 55 of the renal artery RA. That is, thehelical path may comprise a partial arc (i.e., <360°), a complete arc(i.e., 360°) or a more than complete arc (i.e., >360°) along the innerwall of a vessel about the longitudinal axis of the vessel.

FIGS. 4A and 4B illustrate in more detail a distal portion of anintraluminal device 12 configured in accordance with embodiments of thepresent technology. More specifically, FIGS. 4A and 4B illustrate atreatment assembly 21 having an elongate shaping structure 22 helicallywrapped about a deployment member 68 with a plurality of electrodes 24disposed about the shaping structure 22.

In the illustrated embodiment, a distal region or portion of the shapingstructure 22 terminates in an end piece (e.g., a conical orbullet-shaped tip 50) or, alternatively, a collar, shaft, or cap. Thetip 50 can include a rounded distal portion to facilitate atraumaticinsertion of the intraluminal device 12 into a renal artery. A proximalregion or portion of the shaping structure 22 is coupled to and affixedto the elongated shaft 16 of the intraluminal device 12. The elongatedshaft 16 defines a central passageway for passage of a deployment member68. The deployment member 68 may be, for example, a solid wire made froma metal or polymer. The deployment member 68 extends from the elongatedshaft 16 and is affixed to the distal region 22 b of the shapingstructure 22 at the tip 50. Moreover, the deployment member 68 slidablypasses through the elongated shaft 16 to an actuator 36 in a handleassembly 34.

In this embodiment, the deployment member 68 is configured to movedistally and proximally through the elongated shaft 16 so as to move thedistal region of the shaping structure 22 accordingly. Distal andproximal movement of the distal region respectively lengthen and shortenthe axial length of the helix of the shaping structure 22 so as totransform the treatment assembly 21 between a delivery (FIG. 4B) anddeployed state (FIG. 4A) such that the electrodes 24 move a radialdistance to engage the walls of the renal artery (not shown).

In a preferred embodiment, deployment member 68 comprises a hollow tubedefining an internal passage for a guide wire 66 to facilitate insertionof the treatment assembly 21 through an intravascular path to a renalartery. Accordingly, the intraluminal device 12 may be configured for anOTW or RX delivery. The deployment member 68 defines an internal lumenextending through the deployment member and composed of, for example, apolyimide tube with wall thickness less than about 0.003 inch (0.08 mm)(e.g., about 0.001 inch (0.02 mm)) and a lumen with a diameter of lessthan about 0.015 inch (0.38 mm) (e.g., about 0.014 inch (0.36 mm)). Inaddition to engaging and tracking along the guide wire 66, the device 12transforms the configuration of the treatment assembly 21 between thedelivery state and the deployed state.

It should be understood that the embodiments provided herein may be usedin conjunction with one or more electrodes 24. As described in greaterdetail below, the deployed helically-shaped structure carrying theelectrodes 24 is configured to provide a therapeutic energy delivery tothe renal artery without any repositioning. Illustrative embodiments ofthe electrodes 24 are shown in FIGS. 5A-5C. The electrodes 24 associatedwith the shaping structure 22 may be separate elements or may be anintegral part of the shaping structure 22. In some patients, it may bedesirable to use the electrode(s) 24 to create a single lesion ormultiple focal lesions that are spaced around the circumference of therenal artery. A single focal lesion with desired longitudinal and/orcircumferential dimensions, one or more full-circle lesions, multiplecircumferentially spaced focal lesions at a common longitudinalposition, spiral-shaped lesions, interrupted spiral lesions, generallylinear lesions, and/or multiple longitudinally spaced discrete focallesions at a common circumferential position alternatively oradditionally may be created. In still further embodiments, theelectrodes 24 may be used to create lesions having a variety of othergeometric shapes or patterns.

Depending on the size, shape, and number of the electrodes 24, theformed lesions may be spaced apart around the circumference of the renalartery and the same formed lesions also may be spaced apart along thelongitudinal axis of the renal artery. In particular embodiments, it isdesirable for each formed lesion to cover at least 10% of the vesselcircumference to increase the probability of affecting the renal plexus.Furthermore, to achieve denervation of the kidney, it is considereddesirable for the formed lesion pattern, as viewed from a proximal ordistal end of the vessel, to extend at least approximately all the wayaround the circumference of the renal artery. In other words, eachformed lesion covers an arc of the circumference, and each of thelesions, as viewed from an end of the vessel, abut or overlap adjacentor other lesions in the pattern to create either an actualcircumferential lesion or a virtually circumferential lesion. The formedlesions defining an actual circumferential lesion lie in a single planeperpendicular to a longitudinal axis of the renal artery. A virtuallycircumferential lesion is defined by multiple lesions that may not alllie in a single perpendicular plane, although more than one lesion ofthe pattern can be so formed. At least one of the formed lesionscomprising the virtually circumferential lesion is axially spaced apartfrom other lesions. In a non-limiting example, a virtuallycircumferential lesion can comprise six lesions created in a singlehelical pattern along the renal artery such that each lesion spans anarc extending along at least one sixth of the vessel circumference suchthat the resulting pattern of lesions completely encompasses the vesselcircumference when viewed from an end of the vessel. In other examples,however, a virtually circumferential lesion can comprise a differentnumber of lesions. It is also desirable that each lesion be sufficientlydeep to penetrate into and beyond the adventitia to thereby affect therenal plexus. However, lesions that are too deep (e.g., >5 mm) run therisk of interfering with non-target tissue and tissue structures (e.g.,a renal vein) so a controlled depth of energy treatment is alsodesirable.

Referring back to FIG. 3B, the individual electrodes 24 are connected toenergy generator 26 (FIG. 1) and are sized and configured to contact aninternal wall of the renal artery. In the illustrated embodiment, theelectrode 24 may be operated in a monopolar or unipolar mode. In thisarrangement, a return path for the applied RF electric field isestablished, e.g., by an external dispersive electrode (shown as element38 in FIGS. 1 and 2), also called an indifferent electrode or neutralelectrode. The monopolar application of RF electric field energy servesto ohmically or resistively heat tissue in the vicinity of theelectrode. The application of the RF electrical field thermally injurestissue. The treatment objective is to thermally induce neuromodulation(e.g., necrosis, thermal alteration or ablation) in the targeted neuralfibers. The thermal injury forms a lesion in the vessel wall.Alternatively, a RF electrical field may be delivered with anoscillating or pulsed intensity that does not thermally injure thetissue whereby neuromodulation in the targeted nerves is accomplished byelectrical modification of the nerve signals.

The active surface area of the electrode 24 is defined as the energytransmitting area of the element 24 that may be placed in intimatecontact against tissue. Too much contact area between the electrode andthe vessel wall may create unduly high temperatures at or around theinterface between the tissue and the electrode, thereby creatingexcessive heat generation at this interface. This excessive heat maycreate a lesion that is circumferentially too large. This may also leadto undesirable thermal application to the vessel wall. In someinstances, too much contact can also lead to small, shallow lesions. Toolittle contact between the electrode and the vessel wall may result insuperficial heating of the vessel wall, thereby creating a lesion thatis too small (e.g., <10% of vessel circumference) and/or too shallow.

In certain embodiments, the shaping structure 22 may be formed of anelectrically conductive material. For example, the shaping structure 22may be made from nitinol wire, cable, or tube. As shown in FIG. 5C, wireleads 19 may connect the shaping structure 22 to energy generator 26.The shaping structure 22 forms a contact region with the renal arterywall and acts as the electrode 24. In this configuration, the shapingstructure 22 is capable of producing a continuous helical lesion. Ashaping structure 22 that is configured to be an electrode 24 mayoptionally comprise sensors positioned on, in, and/or proximate to theshaping structure 22 and may be electrically connected to supply wires.

In other embodiments, the electrically conductive shaping structure 22is insulated at least in part. That is, the conductive shaping structureis partially covered with an electrically insulating material and theuncovered portions of the shaping structure 22 serve as one or moreconductive electrodes 24. The electrodes 24 may be any size, shape, ornumber, and may be positioned relative to one another as providedherein.

Electrode 24 may be configured to deliver thermal energy, i.e., to heatup and conduct thermal energy to tissue. For example, electrodes may bean electrically resistive element such as a thermistor or a coil madefrom electrically resistive wire so that when electrical current ispassed through the electrode heat is produced. An electrically resistivewire may be for example an alloy such as nickel-chromium with a diameterfor example between 48 and 30 AWG. The resistive wire may beelectrically insulated for example with polyimide enamel.

Turning now to a novel and advantageous embodiment which is a variationon the kind that is shown in FIGS. 4A and 4B: It has been determined byempirical study that helical shaping structures of this general kind,when expanded in order to make contact between the electrodes 24 and thevascular wall 55 (as in FIG. 3B), may tend to result in a contactpressure at each individual electrode which is unevenly distributedalong the length of the shaping structure. For example the distal andproximal electrodes may tend to exert less pressure on the vascular wallthan the center electrode(s). This outcome is undesirable because it iswell established that electrodes that are in contact with a vessel wallwith a greater pressure tend to deliver a greater amount of energy tothe vascular tissue and target nerves. It is therefore desirable to havea helical shaping structure in which the distinct pressures between thevarious electrodes and the vessel wall are evenly distributed along thelength of the shaping structure so that the energy delivered may also beevenly distributed. In order to achieve this objective, a novel systemand method has been invented for a helical shaping structure carrying aplurality of electrodes.

In one embodiment, the invention is a method of manufacturing a helicalshaping structure for carrying electrodes in an RF ablation system andwhich addresses problems in the art. Initially, a cylindrical templatemandrel is prepared. As seen in FIGS. 6A-C through FIG. 8, in someembodiments, a short metallic cylinder 100 may be cut from a longermetal rod, leaving a cylinder about 8 mm in diameter and about 90 mm inlength. In an embodiment exemplified in FIG. 6A, a hole 102 may bedrilled down the axis C-C of the cylinder to provide a continuous borefrom one end to the other. Then, two radially oriented holes 104, 106may be formed for example by drilling into the cylinder from itsexternal curved surface along axes A-A and B-B to meet up with axialhole 102, perpendicularly in some embodiments. In another embodimentexemplified in FIG. 6B, a central hole may be formed in two stages, bydrilling an axial first hole 102 a in from one end but not completely tothe center of the cylinder. Then, a second axial hole 102 b may bedrilled in from the opposite end, also not to the center of thecylinder. Thereafter, two radial holes 104, 106 may be drilled from thesurface of the cylinder to meet up with the axial hole(s). In yetanother embodiment exemplified in FIG. 6C, radial holes 104′, 106′ maybe drilled along axes A′-A′ and B′-B′ respectively which lie in a radialplane of the cylindrical mandrel, but which are each drilled at an angleβ to the central axis C-C. The angle β (beta) may range from 70 degrees,and at the limit, represented by the embodiment in FIGS. 6A and 6B, maybe 90 degrees. Once the mandrel is complete, the lip of each radial holeat its point of entry into the cylinder may be angled to provide agently angled entry point for a wire element that will eventually beinserted therein. In other embodiments, the radial holes 104, 106 or104′, 106′ may be offset from each other in a circular plane about thecentral axis C-C so that they do not lie in the same radial plane. Thiseffect is exemplified by comparing FIG. 6AA with FIG. 6AB. FIG. 6AA isan end view of a mandrel such as the mandrel in FIG. 6A and FIG. 8, inwhich the radial holes along axes A-A and B-B respectively lie on asingle radial plane. FIG. 6AB shows that the axis B-B of second radialhole 106 has been rotated by an angle α (alpha) about the central axis,and no longer shares the same radial plane as hole 104. In theembodiment exemplified in FIG. 6AB, the angle α is ninety degrees, orπ/2 radians.

In one example, and with reference to FIG. 7, the dimensions of oneembodiment of a shaping mandrel 100 may be as follows: Outer Diameter,D, 8 mm; Inner Diameter, d, 2 mm; wall thickness, R, 3 mm; radial holespacing, S, 11 mm; length, L, 90 mm; radial holes, d, 2 mm.

In another embodiment, the cylinder 100 may be formed from a ceramicmaterial suitable for withstanding temperatures up to 600° F. The holesmay be formed by drilling holes in the ceramic material before thematerial is completely set hard, after which it is set hard by heatingor other known process. Alternatively, cylindrical shafts may beinserted into the ceramic material while it is still in a malleablecondition to impart the desired shape to the finished product. When theceramic material is set sufficiently hard, the shafts may be removed,and the ceramic may be hardened by heating.

Once the holes are thus formed in the cylinder, a length of metal wiremay be chosen to form a shaping structure 22′ that will be applied tothe tip of the catheter 16. In one embodiment, the metal wire maycomprise a shape memory alloy such as a Nickel Titanium alloy, and willhave the form of an elongate length of cylindrical wire. The length ofmetal wire is then threaded into the holes 104, 106, 102 formed in thecylinder, as exemplified in FIG. 7 and FIG. 8. This may be easilyaccomplished by threading one end of the wire down first radial hole104, and the opposite end of the wire down second radial hole 106. Smallbends may be pre-applied to the ends of the wire so that the wire can bethreadingly turned around the corner at the end of the radial holes, andthence to emerge from opposite ends of the axial hole 102, as may beseen in FIGS. 7 and 8. It will be appreciated that in an embodiment inwhich the axial hole 102 does not extend all the way through thecylinder (such as exemplified in FIG. 6B), but terminates at the pointof intersection with the radial holes 102, 104, threading the wirethrough the cylinder may actually be slightly easier because the wiredoes not have the “option” of turning towards the center of the cylinderwhen inserted down a radial hole. Once the wire is thus threaded throughthe mandrel, the ends are pulled taut and clamped against the mandrel(clamps not shown in the figures).

In a further embodiment, both the metal and the ceramic embodiments ofthe cylinder, once formed, may be split in half along the axis of thecylinder. This feature will facilitate introduction of the wire into,and ultimate removal from, the holes while the two halves of thecylinder are separated. When the wire is satisfactorily placed in theholes, the two halves of the cylinder may be put back together again,and held together by wire or a clamping device during the followingannealing process.

In one embodiment, an annealing process may be applied to the metalwire, and this process may include the following steps. A heating ovenis set to between 510° F. and 540° F. The wire and shaping mandrelassembly are then laid flat inside the oven for 5 minutes. Thereafter,the wire and mandrel are promptly removed and quenched in roomtemperature water for 30 seconds. The metal wire is then removed fromthe shaping mandrel. It will be appreciated that the holes that aredrilled in the mandrel may have a diameter that exceeds the diameter ofthe wire. This oversizing will permit the wire to be easily withdrawnfrom the mandrel without distorting the wire.

The resulting shaping structure 22′ may have, in one embodiment, thefollowing geometric features, which are described here using a threedimensional coordinate system having x, y, and z orthogonal axes, andwith reference to FIG. 12 and FIG. 13. As used herein, the “pitch” ofthe helical shaping structure is the length over which it traverses2πradians (a full circle), or over which it would traverse 2πradians ifextended far enough. As shown in FIG. 7, the pitch of that embodimentcorresponds with the hole spacing, S, of the mandrel. However, in otherembodiments described herein, the pitch may not coincide with the holespacing of the mandrel.

With respect to FIGS. 12 and 13, it is shown that the shaping structuremay include:

A first element (a distal leg) 202 extending along the x-axis such thaty=0, z=0 for all points along the first element, and x may extend forbetween 10 mm and 20 mm in length;

A second element (a proximal leg) 210 extending along the x-axis suchthat y=0, z=0 for all points along the second element, and x may extendfor between 10 mm and 20 mm in length. In geometric terms, for the firstand second elements, r=0 (r is defined below); and

A third element (a helical portion) 206, positioned between and operablyconnected with the first element and the second element, wherein thethird element follows a spiral shape centered about the x axis having aspiral radius r. Here, y=r*cos t, z=r*cost t, x=pitch*(t/2π), wherein ris a radius of the helix, and t is a parameter having the dimension ofradians. The actual length of the third element along the x axis is, inembodiments, between 10 mm and 20 mm.

A first connector 204 that is straight is provided to extend between aproximal end of the first element 202 and a distal end of the thirdelement 206, wherein the first connector 204 forms an angle β (beta) ofbetween 70 degrees and 90 degrees with the x-axis as shown in FIG. 12.It will be understood that the angle β here will be the same angle β asthat given to the holes 140 and 106 in the mandrel 100″ and seen in FIG.6C and will acquire that magnitude during the annealing process.

A second connector 208 that is straight is provided to extend between adistal end of the second element 210 and a proximal end of the thirdelement 206, wherein the second connector 208 forms an angle β (beta) ofbetween 70 degrees and 90 degrees with the x-axis. It will be understoodthat the angle β will be the same angle β as that given to the mandrel100″ and seen in FIG. 6C and will acquire that magnitude during theannealing process.

Once a shaping structure is formed according to one of the abovedescribed embodiments, it may be connected to the distal tip of adelivery catheter, as seen in FIG. 9 and FIG. 10. In these figures, allthe features of a treatment assembly 21 such as previously described areprovided, except that in the present embodiment the shaping structure22′ replaces the shaping structure 22 previously described and seen inFIGS. 4A and 4B. It will be understood with reference to FIGS. 9 and 10that the shaping structure 22′ presents a helical shape that isgeometrically different than a shape that results by merely stretching ashaping structure in the form of a straight wire along the tip of acatheter, and wrapping it around the deployment member 68 a desirednumber of revolutions (as may be envisaged with reference to FIG. 4B),before deploying the shaping structure by pulling the deployment member.It has been determined that the resulting novel shape of the shapingstructure 22′ as described by the present application is significantlydifferent, and provides a more even distribution of ablation energy fromthe electrodes in use than that of the embodiment described in relationto FIGS. 4a and 4B.

As previously discussed, energy delivery may be monitored and controlledvia data collected with one or more sensors, such as temperature sensors(e.g., thermocouples, thermistors, etc.), impedance sensors, pressuresensors, optical sensors, flow sensors, chemical sensors, etc., whichmay be incorporated into or on the electrodes 24, the shaping structure22′, and/or in/on adjacent areas on the distal portion 20. A sensor maybe incorporated into the electrode(s) 24 in a manner that specifieswhether the sensor(s) are in contact with tissue at the treatment siteand/or are facing blood flow. The ability to specify sensor placementrelative to tissue and blood flow is highly significant, since atemperature gradient across the electrode from the side facing bloodflow to the side in contact with the vessel wall may be up to about 15°C. Significant gradients across the electrode in other sensed data(e.g., flow, pressure, impedance, etc.) also are expected.

The sensor(s) may, for example, be incorporated on the side of one ormore electrodes 24 that contact the vessel wall at the treatment siteduring power and energy delivery or may be incorporated on the opposingside of one or more electrodes 24 that face blood flow during energydelivery, and/or may be incorporated within certain regions of theelectrodes 24 (e.g., distal, proximal, quadrants, etc.). In someembodiments, multiple sensors may be provided at multiple positionsalong the electrode or electrode array and/or relative to blood flow.For example, a plurality of circumferentially and/or longitudinallyspaced sensors may be provided. In one embodiment, a first sensor maycontact the vessel wall during treatment, and a second sensor may faceblood flow.

Additionally or alternatively, various microsensors may be used toacquire data corresponding to the electrodes 24, the vessel wall and/orthe blood flowing across the electrodes 24. For example, arrays of microthermocouples and/or impedance sensors may be implemented to acquiredata along the electrodes 24 or other parts of the intraluminal device.Sensor data may be acquired or monitored prior to, simultaneous with, orafter the delivery of energy or in between pulses of energy, whenapplicable. The monitored data may be used in a feedback loop to bettercontrol therapy, e.g., to determine whether to continue or stoptreatment, and it may facilitate controlled delivery of an increased orreduced power or a longer or shorter duration therapy.

Although preferred illustrative variations of the present invention aredescribed above, it will be apparent to those skilled in the art thatvarious changes and modifications may be made thereto without departingfrom the invention. For example, it will be appreciated thatcombinations of the features of different embodiments may be combined toform another embodiment. Furthermore, although in the describedembodiments the apparatus and methods are for conducting in a bloodvessel, it should be understood that treatment alternatively may beconducted in other body lumens. It is intended in the appended claims tocover all such changes and modifications that fall within the truespirit and scope of the invention.

We claim:
 1. A shaping structure having a generally helical profile andconfigured to support electrodes for delivering electric energy into acylindrical lumen of a patient, the shaping structure comprising: a wirehaving a first end and a second end opposite the first end, formed ofmetal, and having a geometric shape described according to a threedimensional orthogonal coordinate system having an x-axis, a y-axis, anda z-axis, the wire being formed to include: a first element extendingalong the x-axis such that y=0, z=0 at all points on the first element;a second element extending along the x-axis such that y=0, z=0 at allpoints on the second element; and a third element, positioned betweenand operably connected with the first element and the second element,wherein the third element follows a spiral path with an axial length, apitch, p, and a helical radius, r, about the x axis such that for anypoint on the third element, y=r*cos t, z=r*sin t, x=p*(t/2π), where t isa parameter having a dimension in radians; wherein the third element isconnected to the first element by a first connector that is straight andextends between a proximal end of the first element and a distal end ofthe third element, wherein the first connector forms an angle of between70 degrees and 90 degrees with the x-axis; and further wherein the firstend of the wire is attached to an elongate shaft that defines apassageway, and the second end of the wire is attached to an elongateelement that slidably passes through the passageway.
 2. The shapingstructure of claim 1, wherein the third element is connected to thesecond element by a second connector that is straight and extendsbetween a distal end of the second element and a proximal end of thethird element, wherein the second connector forms an angle of between 70degrees and 90 degrees with the x-axis.
 3. The shaping structure ofclaim 1, wherein the first element and the second element are eachbetween 10 and 20 mm in length.
 4. The shaping structure of claim 1,wherein the pitch is between 10 mm and 15 mm.
 5. The shaping structureof claim 1, wherein the radius is between 6 mm and 12 mm.
 6. The shapingstructure of claim 1, wherein the wire is formed of shape memory metal,and has a diameter of between 1.0 mm and 2.0 mm.
 7. The shapingstructure of claim 1, where the length is between 10 mm and 20 mm.